Article: Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B

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TitlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
AuthorsMarcellin, P
Lau, GK
Bonino, F2
Farci, P8
Hadziyannis, S12
Jin, R4
Lu, ZM10
Piratvisuth, T11
Germanidis, G1
Yurdaydin, C5
Diago, M6
Gurel, S9
Lai, MY7
Button, P
Pluck, N
Issue Date2004
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
CitationNew England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa040431
AbstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society
ISSN0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
DOIhttp://dx.doi.org/10.1056/NEJMoa040431
ISI Accession Number IDWOS:000223861300009
DC Field
Value
dc.contributor.authorMarcellin, P
dc.contributor.authorLau, GK
dc.contributor.authorBonino, F
dc.contributor.authorFarci, P
dc.contributor.authorHadziyannis, S
dc.contributor.authorJin, R
dc.contributor.authorLu, ZM
dc.contributor.authorPiratvisuth, T
dc.contributor.authorGermanidis, G
dc.contributor.authorYurdaydin, C
dc.contributor.authorDiago, M
dc.contributor.authorGurel, S
dc.contributor.authorLai, MY
dc.contributor.authorButton, P
dc.contributor.authorPluck, N
dc.date.accessioned2007-03-23T04:38:19Z
dc.date.available2007-03-23T04:38:19Z
dc.date.issued2004
dc.description.abstractBACKGROUND: Available treatments for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B are associated with poor sustained responses. As a result, nucleoside and nucleotide analogues are typically continued indefinitely, a strategy associated with the risk of resistance and unknown long-term safety implications. METHODS: We compared the efficacy and safety of peginterferon alfa-2a (180 microg once weekly) plus placebo, peginterferon alfa-2a plus lamivudine (100 mg daily), and lamivudine alone in 177, 179, and 181 patients with HBeAg-negative chronic hepatitis B, respectively. Patients were treated for 48 weeks and followed for an additional 24 weeks. RESULTS: After 24 weeks of follow-up, the percentage of patients with normalization of alanine aminotransferase levels or hepatitis B virus (HBV) DNA levels below 20,000 copies per milliliter was significantly higher with peginterferon alfa-2a monotherapy (59 percent and 43 percent, respectively) and peginterferon alfa-2a plus lamivudine (60 percent and 44 percent) than with lamivudine monotherapy (44 percent, P=0.004 and P=0.003, respectively; and 29 percent, P=0.007 and P=0.003, respectively). Rates of sustained suppression of HBV DNA to below 400 copies per milliliter were 19 percent with peginterferon alfa-2a monotherapy, 20 percent with combination therapy, and 7 percent with lamivudine alone (P<0.001 for both comparisons with lamivudine alone). Loss of hepatitis B surface antigen occurred in 12 patients in the peginterferon groups, as compared with 0 patients in the group given lamivudine alone. Adverse events, including pyrexia, fatigue, myalgia, and headache, were less frequent with lamivudine monotherapy than with peginterferon alfa-2a monotherapy or combination therapy. CONCLUSIONS: Patients with HBeAg-negative chronic hepatitis B had significantly higher rates of response, sustained for 24 weeks after the cessation of therapy, with peginterferon alfa-2a than with lamivudine. The addition of lamivudine to peginterferon alfa-2a did not improve post-therapy response rates. Copyright 2004 Massachusetts Medical Society
dc.description.naturepublished_or_final_version
dc.format.extent122021 bytes
dc.format.extent3155 bytes
dc.format.mimetypeapplication/pdf
dc.format.mimetypetext/plain
dc.identifier.citationNew England Journal of Medicine, 2004, v. 351 n. 12, p. 1206-1217 [How to Cite?]
DOI: http://dx.doi.org/10.1056/NEJMoa040431
dc.identifier.doihttp://dx.doi.org/10.1056/NEJMoa040431
dc.identifier.hkuros100589
dc.identifier.isiWOS:000223861300009
dc.identifier.issn0028-4793
2011 Impact Factor: 53.298
2011 SCImago Journal Rankings: 3.412
dc.identifier.openurl
dc.identifier.pmid15371578
dc.identifier.scopuseid_2-s2.0-4544239807
dc.identifier.urihttp://hdl.handle.net/10722/43076
dc.languageeng
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License
dc.subject.meshAntiviral agents - adverse effects - therapeutic use
dc.subject.meshHepatitis b, chronic - blood - drug therapy - virology
dc.subject.meshInterferon alfa-2a - adverse effects - therapeutic use
dc.subject.meshLamivudine - adverse effects - therapeutic use
dc.subject.meshPolyethylene glycols - adverse effects - therapeutic use
dc.titlePeginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B
dc.typeArticle
Author Affiliations
  1. Papageorgiou General Hospital
  2. Ospedale Maggiore Policlinico Milano
  3. The University of Hong Kong
  4. Beijing Youan Hospital
  5. Ankara Üniversitesi
  6. Hospital General Universitario de Valencia
  7. National Taiwan University Hospital
  8. Università degli Studi di Cagliari
  9. Uludağ Üniversitesi
  10. Ruijin Hospital
  11. Songklanakarin Hospital
  12. Henry Dunant Hospital